BNR medical device approvals 
 
ACCELERATING the compliance process
All Manufacturers introducing medical devices to the US market must submit an application to the FDA. It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

Most medical devices fall into three categories; Class I, Class II or Class III.  Most Class I devices are exempt from Premarket Notification 510(k) and Premarket Approval (PMA). However, most Class II devices require a 510(k) application and most Class III devices require a PMA prior to marketing of a device in the United States.   BMR BIOMED Solutions will manage the FDA submission process and engage in early collaboration with the FDA which will help avoid delays in your FDA product review and certification including:  
·         Early collaboration with FDA
·         Formatting of FDA documentation
·         Compliance to EMC and Product Safety Electrical Standards
·         Proper device description
·         Substantial equivalent review and discussion
·         Label requirements
·         Bio compatibility requirements
·         Software presentation
·         Bench Tests.
·         Financial Disclosure

Assistance for Europe and international markets:  
·         Medical Device Directive for Europe
·         Quality System (QS) regulation
·         Labeling requirements
·         Medical Device Reporting (MDR)  

Content copyright 2013. BNR Medical Device Approvals. All rights reserved (Division of  Device Approvals Company, LLC) 408-674-9184
 info@bnrmedical.com
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